Clinical TrialAug 13, 2026, 02:34 PM
NeOnc Technologies' NEO100 Phase 2a Shows 48.9% PFS in Glioma
AI Summary
NeOnc Technologies Holdings announced positive Phase 2a results for its intranasal drug NEO100 in recurrent IDH1-mutant high-grade glioma. The study demonstrated a 48.9% six-month progression-free survival rate, significantly exceeding the 20% historical benchmark, and a median overall survival of 26.09 months. The company also highlighted the potential of its intranasal delivery platform, which could extend beyond NEO100 to other CNS therapies, supported by a robust patent portfolio and the advancement of its NEO212 program.
Key Highlights
- NEO100 Phase 2a study showed 48.9% six-month progression-free survival (PFS) in recurrent IDH1-mutant high-grade glioma.
- This PFS rate is nearly 2.5 times better than the pre-specified 20% historical benchmark, with p=0.0047.
- Median overall survival reached 26.09 months.
- 86.7% of patients were alive at six months, 60.9% at 12 months, and 54.1% at 24 months.
- 5 of 24 patients remained on treatment, with one progression-free for approximately 19 months.
- NeOnc holds a portfolio of 179 biotech-related patents, including 28 issued and 14 pending U.S. patents.
- NEO212 Phase 1 dose escalation completed, with a recommended Phase 2 dose of 610 mg.
- NEO100 has FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations.
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